Sebelius, Podesta on Obama's Short List to Replace Daschle

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A top official in the Obama administration says that Kansas Governor Kathleen Sebelius is at the top of the list to replace former Senator Tom Daschle as President Obama’s nominee for Secretary of Health & Human Services, according to the AP/Kansas City Star. This comes after Daschle withdrew his nomination last week, leaving many wondering about the future of U.S. health care reform.

Sebelius has been praised by advocacy groups for the “watchdog role” that she played for eight years as insurance commissioner before she became governor. The Kansas Governor was an early supporter of Obama’s campaign for the presidency. After Obama won the election in November, she was in consideration for several cabinet posts. In early December though, she announced that she had removed herself from consideration for a Washington job, citing Kansas' budget problems that needed her attention.

Also on Obama’s short list is former White House chief of staff under President Clinton, John Podesta, and Tennessee Governor Phil Bredeson. Some advocacy groups are reportedly lining up to oppose the nomination of the Democratic governor from Tennessee. Bredeson remains under consideration but was not as likely as Sebelius to make the final cut, the senior official said.

As governor, Bredesen reduced the state's Medicaid beneficiaries by 170,000 adults in 2005 as a result of budget constraints, and reduced benefits for thousands more TennCare beneficiaries, according to the AP/Austin American-Statesman. In 1980, Bredesen founded a health maintenance organization called HealthAmerica Corp., which became the country's second-largest HMO before he sold it in 1986 for about $400 million.

Critics of Bredesen, who say he has administered the largest public health insurance cuts in U.S. history, say that the cuts illustrate why he is "the wrong person to lead an effort to expand health insurance coverage."

Others argue that Bredesen had to make difficult decisions that ultimately led to the preservation of Tennessee's struggling health care system, thereby averting disaster.

In the Wake of Daschle's Withdrawal, Obama Signs Bill to Expand SCHIP Coverage

President Obama signed the bill extending health coverage to millions of low-income children yesterday after it the House gave final approval, according to The New York Times. Many see this as a signal of the president’s clear intention to guarantee coverage for all Americans.

Since August 2007, the House has voted at least seven times for legislation to expand the popular State Children’s Health Insurance Program. In a recent blog we explained how Former-president George W. Bush twice vetoed similar legislation. Bush adamantly opposed the legislation on the ground that it would lead to “government-run health care for every American,” reports The Times.

Rep. Henry A. Waxman, a California Democrat said that the bill was “a down payment” and “an essential start” to the ultimate goal of health reform. Speaker Nancy Pelosi proclaimed the passage and signing of the bill as the result of the last fall’s historic presidential election, stating:

“This is the beginning of the change that the American people voted for in the last election, and that we will achieve with President Barack Obama.”

One of the major features of the bill is that it allows states to cover certain legal immigrants, who are currently barred from Medicaid and the State Children’s Health Insurance Program for five years after they enter the United States.

According to The Times:

“The bill requires states to verify that people covered by the children’s health program are United States citizens or legal residents. But states are given a new option. Instead of requiring people to produce documents showing citizenship, states can try to verify eligibility by matching a person’s name and Social Security number against federal records.”

In addition to allowing states to extend coverage to legal immigrants without requiring five years of residence, the bill also requires states to provide dental care and equal coverage of mental and physicial illnesses – or “mental health parity" – under the children’s health program.

Expansion of the State Children’s Health Insurance Program comes as Tom Daschle’s withdrawal from nomination for Secretary of Health & Human Services has many worried that the "overhaul" of the U.S. health care system could be seriously delayed, according to Medical News Today.

"Obama is unlikely to find someone with both the health policy experience and congressional connections of Daschle,"

reports CQ Today.

Health & Taxes

Only a few short months ago, Barack Obama was elected President of the United States of America. Supporters rejoiced, “Yes we did!” Shortly after that historic event, then President-elect Obama announced his nomination of former senator Tom Daschle to be his secretary of health and human services. Advocates of universal health care reform were ecstatic.

With the release of Critical: What We Can Do About the Health-Care Crisis and his nomination for U.S. Secretary of Health and Human Services, it seemed that Tom Daschle was the solution to all of our nation's health care woes: a fragmented and inefficient patchwork of public and private payors, rising costs, too many government ties to the private sector, and a lack of uniformity on the proper spelling of “health care."

Yet it appears that that dream is over: Daschle announced today that he is withdrawing his nomination for Secretary of Health and Human Services. CNN.com reports that, in announcing his withdrawal, Daschle said:

“[I]f 30 years of exposure to the challenges inherent in our system has taught me anything, it has taught me that this work will require a leader who can operate with the full faith of Congress and the American people, and without distraction."

The president said Tuesday he accepts Daschle's decision "with sadness and regret," according to CNN.com.

Daschle’s withdrawal comes just hours after a New York Times editorial was published calling for him to step down. Citing Daschle’s “failure to pay substantial taxes that were owed and his sizable income from health-related companies while he worked in the private sector, “ The Times stated its belief that:

“Mr. Daschle ought to step aside and let the president choose a less-blemished successor.”

The Times furthered its demand, stating:

“Mr. Daschle’s financial ties to major players in the health care industry may prove to be even more troublesome as health reform efforts proceed. Like many former power players in Washington, Mr. Daschle cashed in on his political savvy and influence to earn $5 million in recent years, including more than $2 million from Alston & Bird, a law and lobbying firm; more than $2 million from the private equity firm, InterMedia Advisors, which provided the car and driver; and hundreds of thousands of dollars for speeches to interest groups, including those representing health insurance plans, medical equipment distributors and pharmacy boards.”

and

“Although Mr. Daschle was not a registered lobbyist, he offered policy advice to the UnitedHealth Group, a huge insurance conglomerate. He was also a trustee of the Mayo Clinic in Minnesota, on whose behalf he voiced opposition to a federal loan for a freight rail line near the clinic’s headquarters in Rochester, Minn.”

White House press secretary Robert Gibbs said on Tuesday that while the president is disappointed at Daschle's withdrawal, the issue of health reform is “bigger than any one person.” Gibbs stated that the Obama administration has set the bar for ethics “higher than any administration in the history of the United States.”

News of Daschle's withdrawal is sure to bring criticism to President Obama for his cabinet choices, especially in light of the recent controversy surrounding Timothy Geithner's failure to pay taxes.

FDA Scientists Say FDA is “Fundamentally [More] Broken”

Just this last week we posted that a group of nine FDA scientists from the Center for Devices and Radiological Health-- which is responsible for medical devices ranging from stents and breast implants to MRIs and other imaging machinery—authored a letter which asserted that “The FDA is "fundamentally broken" and requires reforms.”

We wrote:

With what A.P refers to as an “unusually blunt letter,” the group of federal scientists contacted "John Podesta, head of the transition team, as well as former Senate Majority Leader and HHS Secretary-designate Tom Daschle (D-S.D.); Baltimore Health Commissioner Joshua Sharfstein, who has led a team assembled by Obama to assess FDA; Senate Health, Education, Labor and Pensions Committee Chair Edward Kennedy (D-Mass.); and eight other lawmakers," according to Kaiser.

In that post, we also called attention to the contention of the scientists that “Managers with incompatible, discordant and irrelevant scientific and clinical expertise in devices...have ignored serious safety and effectiveness concerns of FDA experts.”

Noting that

To say that these managers had “incompatible” and “discordant” scientific and clinical expertise in devices is one thing. One expects a certain degree of disagreement within the scientific community—and to some extent, one reasonably relies upon the crucible of such “discordant” viewpoints in scientific debate to provide tested answers to real problems. But the scientists who wrote this letter added one more word: “irrelevant.” And in this context, that leaves us uncomfortably with the knowledge that in the estimation of these nine scientists, the determining force in these particular scientific inquiries—the managers—lack relevant scientific expertise in the pertinent subject matter—medical devices.

Apparently, the “expertise” at issue in the approval of a breast cancer imaging device is alleged to go somewhat beyond the scientific.

The New York Times reports that it has obtained various FDA emails and internal documents which underlie the scientists’ complaint and are the present subject of both an FDA internal inquiry and a congressional investigation. The emails and documents are said to provide details of the investigations which had not previously been made public.

The New York Times reports that

An official at the Food and Drug Administration overruled front-line agency scientists and approved the sale of an imaging device for breast cancer after receiving a phone call from a Connecticut congressman, according to internal agency documents.

The congressman is Republican Chris Shay, who lost re-election in November. A component of the imaging device was produced by a Fujifilm Medical Systems, which “is based in Stamford, Conn., the heart of Mr. Shays’s former district,” according to the NY Times.

The article also states that

The legislator’s call and its effect on what is supposed to be a science-based approval process is only one of many of accusations in a trove of documents regarding disputes within the agency’s office of device evaluation.

Read more here.

FDA Scientists Say that FDA is "Fundamentally Broken"

“The FDA is "fundamentally broken" and requires reforms, according to a letter sent to the transition team of President-elect Barack Obama by nine agency scientists, Dow Jones reports." (Kaiser.org 1/8/08).

With what A.P refers to as an “unusually blunt letter,” the group of federal scientists contacted "John Podesta, head of the transition team, as well as former Senate Majority Leader and HHS Secretary-designate Tom Daschle (D-S.D.); Baltimore Health Commissioner Joshua Sharfstein, who has led a team assembled by Obama to assess FDA; Senate Health, Education, Labor and Pensions Committee Chair Edward Kennedy (D-Mass.); and eight other lawmakers," according to Kaiser.

A.P reports that the letter was written on FDA Center for Devices and Radiological Health letterhead; “the center is responsible for medical devices ranging from stents and breast implants to MRIs and other imaging machinery.”

The letter reads in part as follows:

The purpose of this letter is to inform you that the scientific review process for medical devices at the FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk. Managers with incompatible, discordant and irrelevant scientific and clinical expertise in devices...have ignored serious safety and effectiveness concerns of FDA experts. Managers have ordered, intimidated and coerced FDA experts to modify scientific evaluations, conclusions and recommendations in violation of the laws, rules and regulations, and to accept clinical and technical data that is not scientifically valid. (emphasis added)

To say that these managers had “incompatible” and “discordant” scientific and clinical expertise in devices is one thing. One expects a certain degree of disagreement within the scientific community—and to some extent, one reasonably relies upon the crucible of such “discordant” viewpoints in scientific debate to provide tested answers to real problems. But the scientists who wrote this letter added one more word: “irrelevant.” And in this context, that leaves us uncomfortably with the knowledge that in the estimation of these nine scientists, the determining force in these particular scientific inquiries—the managers—lack relevant scientific expertise in the pertinent subject matter—medical devices.

The Wall Street Journal Health Blog reports that earlier today, HHS Secretary-designate Tom Daschle appeared at “a friendly hearing before the Senate’s Health, Education, Labor and Pensions Committee.” Daschle, who was one of the recipients of the FDA scientists’ letter, did not mention it in his prepared speech. Daschle did, however, state the following:

Unfortunately, there is growing concern that the FDA may have lost the confidence of the public and Congress — much to our detriment. When Americans are nervous about eating spinach or tomatoes or cantaloupes, that’s not good for our health and it is terrible for our farmers. When nearly two-thirds of Americans do not trust the FDA’s ability to ensure the safety and effectiveness of pharmaceuticals, the result is Americans may hesitate to take important medications that protect their health. This is unacceptable.

LA Times on Daschle Plan & Strategy

The Los Angeles Times looks at what a Tom Daschle plan might look like and how it would be implemented politically. Read story here.

It’s Official, Daschle nominated to head HHS and new White House Office of Health Reform.

In a press conference, President-elect Obama announced his choice of former Senate Majority Leader Tom Daschle to head both Health and Human Services (HHS) and the new White House Office of Health Reform. "As such he will be responsible not just for implementing our health care plan. He will also be the lead architect of that plan," Obama said. Jeanne Lambrew was picked to serve as deputy director of the White House office. She served as a health and economics adviser during the Clinton administration. Read full story here.